CN107660142A - 用于血管内温度管理导管和/或热交换垫片的热交换器中的冷板设计 - Google Patents

用于血管内温度管理导管和/或热交换垫片的热交换器中的冷板设计 Download PDF

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CN107660142A
CN107660142A CN201680031530.XA CN201680031530A CN107660142A CN 107660142 A CN107660142 A CN 107660142A CN 201680031530 A CN201680031530 A CN 201680031530A CN 107660142 A CN107660142 A CN 107660142A
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J·T·德布罗维克
C·W·彭德里
C·M·皮斯特
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Zoll Circulation Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/12Devices for heating or cooling internal body cavities
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/0085Devices for generating hot or cold treatment fluids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/02Compresses or poultices for effecting heating or cooling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/08Warming pads, pans or mats; Hot-water bottles
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F28HEAT EXCHANGE IN GENERAL
    • F28DHEAT-EXCHANGE APPARATUS, NOT PROVIDED FOR IN ANOTHER SUBCLASS, IN WHICH THE HEAT-EXCHANGE MEDIA DO NOT COME INTO DIRECT CONTACT
    • F28D7/00Heat-exchange apparatus having stationary tubular conduit assemblies for both heat-exchange media, the media being in contact with different sides of a conduit wall
    • F28D7/0066Multi-circuit heat-exchangers, e.g. integrating different heat exchange sections in the same unit or heat-exchangers for more than two fluids
    • F28D7/0075Multi-circuit heat-exchangers, e.g. integrating different heat exchange sections in the same unit or heat-exchangers for more than two fluids with particular circuits for the same heat exchange medium, e.g. with the same heat exchange medium flowing through sections having different heat exchange capacities or for heating or cooling the same heat exchange medium at different temperatures
    • AHUMAN NECESSITIES
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0054Heating or cooling appliances for medical or therapeutic treatment of the human body with a closed fluid circuit, e.g. hot water
    • A61F2007/0056Heating or cooling appliances for medical or therapeutic treatment of the human body with a closed fluid circuit, e.g. hot water for cooling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/12Devices for heating or cooling internal body cavities
    • A61F2007/126Devices for heating or cooling internal body cavities for invasive application, e.g. for introducing into blood vessels

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Abstract

冷却剂所流过的冷板(30、32)限定了在冷板(30、32)之间的能够接收盒(50)的槽(34),其中来自血管内热交换导管(12)或外部垫片(18)的具有相对低的流率的无菌工作流体流过盒(50)。槽(34)可以沿着边缘具有凸起腔(R1、R2)以允许盒的膜扩展并因此建立流体供给和返回通道。

Description

用于血管内温度管理导管和/或热交换垫片的热交换器中的 冷板设计
技术领域
本申请大体涉及用于控制患者体温的热交换系统。
背景技术
已经引进患者体温控制系统来防止神经重症监护室中的患者由于患有蛛网膜下腔出血或诸如中风等的其它神经系统疾病而发热。此外,该系统已经用于诱导轻度或中度低体温以改善患有诸如中风、心搏停止、心肌梗塞、外伤性脑损伤和高颅内压等的疾病的患者的治疗效果。血管内热交换导管的示例在以下美国专利中公开:No.7,914,564、No.6,416,533、No.6,409,747、No.6,405,080、No.6,393,320、No.6,368,304、No.6,338,727、No.6,299,599、No.6,290,717、No.6,287,326、No.6,165,207、No.6,149,670、No.6,146,411、No.6,126,684、No.6,306,161、No.6,264,679、No.6,231,594、No.6,149,676、No.6,149,673、No.6,110,168、No.5,989,238、No.5,879,329、No.5,837,003、No.6,383,210、No.6,379,378、No.6,364,899、No.6,325,818、No.6,312,452、No.6,261,312、No.6,254,626、No.6,251,130、No.6,251,129、No.6,245,095、No.6,238,428、No.6,235,048、No.6,231,595、No.6,224,624、No.6,149,677、No.6,096,068、No.6,042,559、No.8,888,729和USPPs 2013/0178923、2013/0079855、2013/0079856、2014/0094880、2014/0094882、2014/0094883,其所有内容通过引用并入本文。
可以使用外部患者体温控制系统。该系统在以下美国专利中公开:No.6,827,728、No.6,818,012、No.6,802,855、No.6,799,063、No.6,764,391、No.6,692,518、No.6,669,715、No.6,660,027、No.6,648,905、No.6,645,232、No.6,620,187、No.6,461,379、No.6,375,674、No.6,197,045和No.6,188,930(共同地,“外部垫片专利”),其所有内容通过引用并入本文。还通过引用并入本文的是本受让人的美国专利申请14/276,202。
在也通过引用并入本文的本受让人的USPN 7,070,612中,能够接收血管内热交换导管和外部热交换垫片两者的工作流体环路的线圈的热交换控制台已经被说明并取得专利权。总之,在所有的血管内和外部患者体温控制方案中,流过导管或垫片的工作流体的温度是通过基于由患者的实际体温提供的反馈的热交换控制台来调节的,典型地,核心体温可以是各种在直肠中测量的、在食管中测量的、耳鼓室温度、例如腔静脉等中的血液温度。通过使工作流体与控制台中的加热和/或冷却元件热耦合来调节工作流体温度。
发明内容
一种包括板组件的装置,其中板组件具有构造成接收盒的膜组件的盒槽,而膜组件被构造成容纳来自血管内热交换导管、外部热交换垫片或其它形态的患者热交换构件的工作流体。板组件还包括跨立槽的各侧并被构造成接收盒的各侧导轨(rail)的导轨收容部。至少第一凸起腔、收容部或凹槽在第一个导轨收容部的内侧形成。第一凸起腔在其最宽点处可以具有大于槽的宽度的直径或宽度。
在示例中,第二凸起腔、收容部或凹槽在第二个导轨收容部的内侧形成。第二腔在其最宽点处可以具有大于槽的宽度的直径或宽度。两个凸起腔均与槽的各侧接合。在特定的实施方式中,第一和/或第二凸起腔在其最宽点处可以具有小于第一或第二导轨收容部的横向直径或宽度且/或大于槽的宽度的直径或宽度。
当通过使膜组件布置在槽中并且使盒的侧导轨布置在导轨收容部中而使盒与装置接合时,膜的在盒的侧导轨内侧的例如膜组件边缘附近的第一部分能够在膜组件充填工作流体时扩展进入第一凸起腔,从而沿着膜组件的竖直侧边缘建立扩大的流体通道。第一凸起腔可以大致延伸第一导轨收容部的整个长度,并且可以是圆形或半圆形、菱形或其它形状的。
在另一方面,一种包括板组件的装置,其中板组件又包括分隔板,该分隔板在分隔板的第一侧形成有第一流路,在分隔板的与第一侧相反的第二侧形成有第二流路。第一流路被构造成从压缩机接收通过压缩机的冷却剂,而第二流路被构造成接收来自患者热交换垫片或者来自除垫片之外的水源或其它流体源的水或其它流体。第一垫板抵接分隔板的第一侧而第二垫板抵接分隔板的第二侧。腔与和分隔板相对的第一垫板接界并且被构造成接收盒,所述盒被构造成保持循环通过血管内热交换导管的工作流体。
在一些示例中,第一和第二垫板沿着分隔板的整个或大致整个第一和第二侧抵接分隔板的第一和第二侧,而仅第一和第二流路建立了各流体可以流过的腔。流路中的一者或两者可以是蛇行形状的。
利用该结构,第一流路中的冷却剂能够与布置在腔内的盒中的流体交换热量。同样地,第一流路中的冷却剂能够隔着分隔板与第二流路中的流体交换热量。此外,第二流路中的流体能够隔着分隔板和第一垫板与布置在腔内的盒中的流体交换热量。可以建立通过第一流路的冷却剂流动,以遍及通过第一流路的冷却剂的横断面地维持一些液相。在特定的实施方式中,考虑其它板组件,其可以具有被构造成用于接收来自患者热交换垫片或者来自另外的水源或其它流体源(例如,已经被冷却或加热的流体源)的水或其它流体的一个或多个流路,其中流路中的流体或水能够与布置在板组件中的盒中的流体交换热量。
在另一方面,与来自血管内热交换导管或者来自外部热交换垫片或其它形态的患者热交换构件的工作流体交换热量的热交换系统包括至少一个压缩机,该压缩机被构造成使冷却剂循环通过系统以与工作流体交换热量。至少一个管道、管或接口(port)被构造成接收来自压缩机的排放热并且将排放热导向患者。
在特定的实施方式中,与来自血管内热交换导管或者来自外部热交换垫片或其它形态的患者热交换构件的工作流体交换热量的热交换系统可以包括具有一个或多个流路的板组件。流路可以被构造成接收通过流路的冷却剂,其中建立或调节通过流路的冷却剂流以遍及通过流路或冷板的冷却剂的横断面地维持至少一些液相并且冷却剂与工作流体交换热量。
参照附图能够最好地理解本文对结构和操作两者进行说明的各种实施方式的细节,其中相同的附图标记表示相同的部件,并且其中:
附图说明
图1是根据实施方式的非限制性系统的示意图;
图2是热交换系统的示例工作流体盒保持件部分的立体图;
图3是图2示出的盒保持件的一半的立体图,假定不透明的金属内表面透明地示出以显示蛇行冷却剂通道;
图4是构造成接合图2和图3示出的盒保持件的示例工作流体盒的立体图;
图5是图2的截面图;
图6是沿着图2的线5-5看到的可选实施方式的截面图;
图7是图2示出的盒槽的可选构造的顶视图;以及
图8是可选的冷板实施方式的截面图,在该实施方式中冷却剂流过分隔板一侧的凹面流路(concave channel)而外部冷却垫片的水或来自冷流体源的水流过分隔板的相反侧的凹面流路;
图9是冷板实施方式的分解图。
具体实施方式
首先参照图1,根据本原理,系统10可以包括由控制系统14控制的血管内热交换导管12以控制患者体温,例如,防止患者16发热或诱导患者16的治疗性低体温。在导管中,诸如但不限于盐水的工作流体或冷却剂在闭环中(典型地受到控制系统中的泵“P”的影响)从控制系统14、通过流体供给管路L1、通过导管12并通过流体返回管路L2返回至系统14地循环,使得没有工作流体或冷却剂进入身体。可以使用以上公开的或以下美国专利中的任何导管,全部内容通过引用并入本文:USPN 6,419,643、6,416,533、6,409,747、6,405,080、6,393,320、6,368,304、6,338,727、6,299,599、6,290,717、6,287,326、6,165,207、6,149,670、6,146,411、6,126,684、6,306,161、6,264,679、6,231,594、6,149,676、6,149,673、6,110,168、5,989,238、5,879,329、5,837,003、6,383,210、6,379,378、6,364,899、6,325,818、6,312,452、6,261,312、6,254,626、6,251,130、6,251,129、6,245,095、6,238,428、6,235,048、6,231,595、6,224,624、6,149,677、6,096,068、6,042,559、8,888,729、5,486,208、5,837,003、6,110,168、6,149,673、6,149,676、6,231,594、6,264,679、6,306,161、6,235,048、6,238,428、6,245,095、6,251,129、6,409,747、6,368,304、6,338,727、6,299,599、6,287,326、6,126,684、7,211,106和USPPs 2013/0178923、2013/0079855、2013/0079856、2014/0094880、2014/0094882、2014/0094883。可以将导管12置于例如上腔静脉或下腔静脉的静脉系统中。
取代导管12或除导管12之外,系统10可以包括一个或多个垫片18,其抵靠患者16的外部皮肤地定位(为了清楚,仅示出了一个垫片18)。不受限制地,垫片18可以是上述外部垫片专利中公开的垫片中的任何一个垫片。能够由控制系统14控制垫片18的温度以与患者16交换热量,包括诱导患者的治疗性轻度或中度低体温,这些患者患有能够通过低体温减轻影响的例如心搏停止、心肌梗塞、中风、高颅内压、外伤性脑损伤或其它疾病。垫片18可以通过流体供给管路L3从系统14接收工作流体,并且通过流体返回管路L4使工作流体返回系统14。
控制系统14可以包括接收目标和患者体温作为输入和控制的一个或多个微处理器20,此外可以包括泵“P”、冷却剂压缩机22和/或能够打开以允许冷却剂绕过冷凝器的旁路阀24。冷却剂在控制系统14中循环通过热交换器并且在以下进一步说明。处理器20可以访问在计算机存储器26上的指令,使处理器20配置为执行以下讨论的逻辑。计算机存储器26可以是例如磁盘或固态存储器。
来自压缩机22或风扇的温暖的排放空气可以直接被引导通过管道27来温暖患者16。尽管图1示出了管道27具有邻近患者的开口端,但应当理解的是管道27可以引导空气进入毯子、帐篷或者部分或完全包围患者的其它覆盖物。
在其它实施方式中,由系统10例如由压缩机或系统的任何其它部件产生的热可以被传送或引导至患者的表面,以在利用热交换导管或垫片冷却患者之前、之后或过程中温暖患者。
图1还示出了在缺乏用于压缩机22的冷却剂或缺乏电力或不能使冷却剂循环通过系统来冷却导管12的工作流体的其它原因的情况下,如果仍然期望冷却导管12的工作流体,可以将诸如冷水浴等的源28连接到垫片流体管路L3和L4,以将冷流体提供给系统来冷却导管工作流体。以下进一步讨论细节。
图2示出了在控制系统14中的示例热交换器的一部分,其包括至少两个冷板30、32,冷板30、32限定了在它们之间的盒槽34。在一个实施方式中,槽34的宽度“W”小于四十密耳(0.040”),并且可能在二十九密耳与三十一密耳之间(0.029”-0.031”)。在其它实施方式中,槽的宽度在0.020”-0.070”密耳之间。在特定的示例中,宽度“W”可以是三十密耳。如以下进一步详细说明的,在槽34中可以创建冷却剂室以接收诸如但不限于盒的热交换构件,来自血管内热交换导管、外部热交换垫片、外部冷却垫片或其它形态的患者热交换构件的工作流体流动通过该盒。因为热交换通过热交换构件的壁进行,所以来自导管或垫片的工作流体在热交换构件的壁之外不与控制系统14的热交换器中的任何表面或流体接触。以这种方式,循环通过血管内导管或垫片的、在非限制性示例中典型为盐水的工作流体能够保持无菌。因此,首先将关注集中于由槽34创建的冷却剂室。
冷板30、32可以由金属或其它导热材料制成,并且如所示出的可以是直线式的以及确实可以是接近方形的。冷板30、32可以沿着左右侧壁36彼此抵接,而细长的竖直盒框架收容部R1和R2位于各侧壁36的紧接内侧并且槽34在壁36之间延伸并如所示出的终止于收容部R1、R2。框架收容部R1、R2可以宽于槽34。在所示的示例中,冷却剂入口管38和出口管40延伸通过至少一个冷板32以使来自压缩机22的冷却剂连通进入冷板中的冷却剂通道,这在由槽34所创建的第一冷却剂室之外创建了第二冷却剂室(并且该第二冷却剂室与第一冷却剂室热接触)。各冷板可以具有其自身的冷却剂入口和出口管,或者各冷板可以具有入口或者出口,例如在冷板的冷却剂通道彼此流体连通的情况下,又或者在所示出的实施方式中,可以仅一个冷板形成有冷却剂入口和出口管,而另一冷板与流动有冷却剂的前述冷板热耦合,和/或通过贯穿一个或两个侧壁36形成的通道接收来自另一冷板的冷却剂。
在一个示例中,如所示出的,垫片工作流体入口Pin和出口Pout还可以形成于至少一个冷板中。如以下更详细地讨论的,经由管路L3和L4或者其它管路的来自垫片18或来自冷流体源28的工作流体可以被转入垫片工作流体入口Pin和出口Pout,以与冷却剂交换热量或者在一些情况下与来自导管的流过冷板的工作流体交换热量。此外,为了提供温暖的工作流体,可以在一个或两个冷板上安装一个或多个电加热器41来加热冷板。或者为了温暖冷板,在气态冷却剂循环通过系统时可以打开旁路阀24(图1)以允许来自压缩机的热的气态冷却剂绕过冷凝器。
图3示出了假定内表面透明地进行观察的示例冷板32的细节,应当理解的是,内表面典型地是金属从而图3中示出的蛇行冷却剂通道42典型地对于人眼是不可见的。在任何情况下,将冷却剂入口38与冷却剂出口40流体连通的示例冷却剂通道可以是如所示出的蛇行形状,或者可以是一些其它形状或样式,诸如人字形样式、波浪形样式、或者卷绕的、弯曲的或蜿蜒的样式,或者具有一条或多条曲线、转弯和/或弯折等的构型。
图4示出了根据本原理的示例工作流体盒50。盒50被构造成紧密地嵌合入限定于冷板30、32之间的槽34和盒框架收容部R1、R2。在操作中,来自诸如导管12或外部垫片的患者可接合的热交换构件的诸如盐水的工作流体流过盒50,同时工作流体与冷板中的冷却剂交换热量。在示例实施方式中,盒50是低成本一次性物品,其能够包含例如循环通过导管12或外部垫片的无菌盐水。盒被医疗护理者放置在冷板30、32之间的槽34中,并且当工作流体流过膜部时,限定了供示例盐水流过的空间或工作流体室的膜部膨胀,实现与冷板30、32的热接触。
在示出的示例中,盒50包括限定了周缘的框架52和如所示的被框架的周缘在至少三侧限界的优选直线式开口。在所示出的非限制性示例中,框架包括细长的平行六面体形状的顶部导轨53和彼此平行并垂直于顶部导轨53的细长的平行六面体形状的左侧和右侧导轨54。示例的框架52可以具有与顶部导轨相对并且连接到左侧和右侧导轨54的金属带或底部导轨51以支撑膜以及促使膜置于双向张力(biaxial tension)中。在任何情况下,示例的框架52是直线式的并且被构造成紧密地接收于两个冷板30、32之间,而侧导轨54与冷板30、32之间的框架收容部R1、R2是可滑动地接合的,通过槽34的下述膜组件与冷板中的冷却剂流路紧密地并置。在特定的变型中,收容部R1、R2可以被锁上或每个均具有对应于盒的侧导轨的形状或构型的不同形状。这会帮助确保盒以正确的方向插入槽和收容部,为使用者提供引导。
在图4中,在所示的示例中的框架的顶部导轨53形成有布置有入口管58的流体入口56和布置有出口管62的流体出口60。入口和出口均创建了通过框架进入开口的各自的流体通道。入口和出口管58、62可以与和导管12关联的流体返回和供给管路L1、L2接合。管58、62中的一者或两者可以终止于顶部导轨53的略下方、与顶部导轨的底部齐平,或者可以延伸任何期望的长度向下到达组件的底部,即管58、62中的一者或两者几乎可以延伸左侧和右侧导轨54的整个长度,在膜组件的下述的底部接缝的略上方终止。在特定的实施方式中,入口和出口管可以延伸足够的长度以允许管与冷板中或冷板上的特征或部件接合,例如管的至少一部分或端段可以安置在位于冷板的内壁或面部的凹槽或台阶中。入口和出口管可以定位成使其与冷板中的凸起腔配合或成直线。该定向可以帮助最小化或防止膜组件以不受控或少受控的方式向外凸出,这可能会导致断裂。在特定的实施方式中,入口和出口管58、62或单独的入口和出口管可以与和外部垫片关联的流体返回和供给管路L3、L4接合。
实际上,例如聚合物膜组件的膜组件64连接至框架52,如所示出的封堵了被框架在四侧限界的开口。该膜组件64包括第一膜66和第二膜68,第一膜66平行于第二膜68并与第二膜68距离很近,在第一膜66与第二膜68之间留下空间创建了工作流体室。流体入口56和流体出口60与膜66、68之间的空间连通。膜66、68中的至少一者、优选两者拉伸地布置于开口中。当膜之间的空间充填工作流体时,该空间是可扩展的。
在一个示例中,每个膜不大于两密耳(0.003”)厚,并且优选地厚度在一密耳至三密耳之间(0.001”-0.003”),包括端点。在特定的实施方式中,每个膜的厚度可以在一密耳至五密耳之间(0.001”-0.005”)。示例膜66、68与开口同延(co-extensive)并且与开口一样是接近方形的,示例膜的顶部边缘和底部边缘的长度与膜的左边缘和右边缘的长度近似相等(差异在±10%以内,更优选地在±5%以内)。在其它实施方式中,取代方形的纵横比(1:1),可以使用上至1:1.5的纵横比。膜之间的工作流体室也是直线式的,并且在特定的实施方式中在膜之间不存在阻碍,意味着工作流体室是接近方形室的完全直线式的。
因为盒与冷板接合时膜66、68的薄、冷板30、32彼此的接近以及与冷板之间的膜组件的接近,所以图中示出的系统为在冷板中循环的冷却剂与膜66、68之间循环的工作流体之间的传热提供低阻抗。归因于工作流体流产生的背压,膜之间的工作流体室膨胀,消除或降低了对冷板中的移动机构的需求。另外,两个冷板之间的窄槽34通过减小冷板与工作流体之间的传导路径的长度提供了更好的传热。框架允许容易的操作,诸如将盒插入冷板/从冷板中移除盒。
对于具有接近1:1的宽-长纵横比(即方形或接近方形)的膜66、68之间的示例工作流体室,与不够方形的构型相比,引导工作流体流过热交换器所要求的背压的量降低。这降低了工作流体泵必须执行的工作量,两个原因使得该降低是所期望的。一是因为泵可以是一次性的,所以较低的性能需求转化为较低成本的一次性且较安静的系统。例如,蠕动滚子泵提供安静的操作和低成本的一次性元件,但是仅在需要适度压力时运转最有效。二是因为减少工作流体泵的工作降低了通过泵自身传输入工作流体的热量。此外,低宽/长纵横比导致使混合量降低的较慢的工作流体速度,但是该在其它方面期望的(从热交换的观点看)效果在本示例系统中是可忽略的,因为雷诺数(Reynolds numbers)典型地<1000,这表明是层流态(laminar flow regime)。另外,低宽/长纵横比显著地降低了在流体流路中的弯折部(或“角部”)的数量。这些弯折部是促进传热的混合流体的区域。没有弯折部时,会建立起流体边界层。然而,通过维持冷板之间的窄槽,该效果在这里被抵消。这种方式中主要传热方法是通过传导,但是传导路径长度(并且因此边界层)是小的,导致了相对高的传热率。
在特定的实施方式中,冷板的面对盒膜的表面可以涂布非粘附(“剥离”)和/或疏水的涂层,以帮助在使用之后移除盒。在一些示例中,归因于在整个使用期间(例如,上至7天)使热交换膜压靠冷板表面的、来自盐水流体流的背压,导致膜粘附在冷板上,移除可能是困难的。大的表面区域可能导致令使用者难以克服的强力。另外,在膜和冷板表面之间可能存在(归因于渗漏、冷凝)水的薄膜而导致额外的毛细管力,该毛细管力在一些情况下可能难以克服并且能够导致盒或冷板的损坏,使得提取困难。非粘附和/或疏水的涂层通过最小化毛细管力使之缓和。另外,该水膜可能完全变干,潜在地导致范德瓦尔斯粘合(Van derWaals adhesion)。涂层的非粘附方面防止该情况发生。含氟聚合物涂层提供疏水和剥离(非粘附)两种特性,并且可以与其它非粘附和/或疏水材料或涂层一起使用。
在特定的示例中,膜66、68在组装至框架的过程中在张力下拉伸,优选地为双向张力(即,在顶部和底部导轨53、51之间的张力下以及左侧和右侧导轨54之间的张力下)。能够在产品的保存期内维持该张力。预张使材料中的褶皱最小化,这是有益的,因为褶皱能够阻碍工作流体流并且创建使工作流体与冷板之间的传热降低的空气间隙。褶皱还能够使膜组件插入窄槽34复杂化。
为了建立膜的预张,框架可以以两个框架半部的形式制成,诸如螺纹紧固件等的柱可以横向地延伸至框架的一半部,而膜66、68在柱上方被拉伸并由制成于膜中的孔接收柱。然后,框架的另一半部定位成使膜组件的直线式边界部分夹在两个框架半部之间,诸如各自的螺母的封闭件与柱接合以使框架半部保持在一起,而膜组件以张力保持在框架半部之间。可选地柱(例如使用压力配合的柱)可以位于一个或多个框架中以使框架半部保持在一起。柱可以由塑料或者其它合适的材料制成。图4示出了工作流体室在底部由膜组件的底部接缝74A封闭,其中底部接缝74A是边界部分的一部分。除了应用张力以避免使用中的褶皱之外,可以使用另外的柱以避免在焊接过程中起皱,改善了焊接接头的质量。
在边界部分中,可以使用至少一层且优选多层的聚合物膜来增强膜66、68以建立焊接接缝,通过该焊接接缝(位于膜组件的侧面)形成柱孔,允许较容易的加工。通过仅在边界部分放置增强层,膜组件的中央“窗口”仅由工作流体与冷板30、32中的一者之间的单层薄膜构成以使对传热的阻碍最小化。可以使用冲切增强层,该增强层利用一件材料增强整个周缘。
在一些示例中,聚合物膜66、68是高度可拉伸的,伸长率至少大于25%。这允许膜从图4示出的空的平坦状态改变成膨胀形状(在冷板之间的槽34内)而不起皱。还允许膜容易地与冷板的面部上的特征相吻合。
另外,膜可以由还能够制成管的材料制成。然后,图4示出的诸如入口和出口管58、62的管能够被热焊接(例如,使用RF密封)至膜,所述热焊接比粘合结合更可靠和快速。因为冷板32、34和框架52为膨胀的膜组件提供支撑,允许膜组件承受流过膜之间的工作流体产生的压力,所以膜66、68不需要提供它们自身的横向支撑。诸如凸起的凸块、凹面、凸起的肋等的结构特征可以位于冷板上以优化传热。例如,冷板的面部可以起皱或者包括提供增加的表面积从而增大或优化膜与冷板之间的热交换或传输的特征(切掉或凸起)。特征可以具有不同的形状或样式,例如蛇行的、卷绕的、弯曲的或蜿蜒的样式或形状,或者可以包括具有一个或多个曲线、转弯和/或弯折的构型。这可以是经济上有利的,因为冷板可以是可再使用的部件。可以将歧管(manifold)切成冷板以使盐水流的分布均匀。
在说明了控制系统14中的热交换器与血管内温度控制导管12或垫片18中的无菌工作流体之间的结构的示例非限制性热交换组合之后,现将关注转向示出冷板中的另外的冷却剂室的示例实施方式的图5,通过该冷却剂室进行与来自外部热交换垫片18的、包括非无菌工作流体的工作流体的热交换。注意,图5示出的板结构优选为金属或其它具有高导热率的材料。
如所示出的,尽管在以下讨论中冷板30、32通常被称为“板”30和32,但冷板30、32可以是限定多流体室的多板组件。在所示出的非限制性示例中,冷却剂入口和出口管38、40贯穿冷板32的外壁80和分隔壁82地延伸,以使来自压缩机22的冷却剂连通进入冷板中的冷却剂通道,这建立了由分隔壁82和内壁84限界的冷却剂室42。在内壁84的另一侧是工作流体盒槽34。如之前所阐明的,每个冷板可以具有其自身的冷却剂入口和/或出口管,或者可以仅一个冷板形成有冷却剂入口和出口管,而另一冷板与流动有冷却剂的前述冷板热耦合,和/或通过形成于冷板之间的通道从另一冷板接收冷却剂。在所示的示例中,冷板30、32通过侧壁36(图2)、共用底壁86(图5)和形成有槽34的顶壁88的不间断部分热耦合。
在一些示例中,冷板30、32是彼此的镜像结构。在图5的示例中,左手侧冷板(32)中的冷却剂室42通过冷却剂供给和返回通道90、92与右手侧冷板30中的冷却剂室94流体连通。因此,冷板的冷却剂室跨立盒槽34并且通过各自的内壁84与盒槽34分离,而冷却剂通过左、右冷却剂室42、94串行地流动:首先从冷却剂入口管38进入左冷却剂室42,然后通过冷却剂供给通道90、右手侧冷却剂室94,通过冷却剂返回通道92返回,并且从冷却剂出口管40出来。当如同示出的示例设置两个冷却剂室时,这增加了冷却剂流体通过冷却剂室42、94的流率。
与此相反,可以对垫片工作流体流路的流体流并行地铺设通路通向左、右垫片流体室106、108,该垫片流体室如所示出的跨立冷却剂室并且通过各自的分隔壁82与冷却剂室分离。在所示的非限制性示例中,来自外部垫片的流体流动通过垫片工作流体入口Pin进入形成于底壁86的入口节气室100。流体并行地流动通过入口端口102、104,进入左、右垫片工作流体室106、108。流体通过形成于顶板88的上节气室110离开垫片工作流体室并且从工作流体出口Pout出来返回至外部垫片。该示例并行流体流降低了在垫片工作流体系统中的背压。
注意,上述通过冷却剂室的串行流体流和通过垫片工作流体室的并行流体流仅是示例性的而非限制性的。因此,通过垫片工作流体室的流体流可以是串行的和/或通过冷却剂室的流体流可以是并行的。还要注意,图示并说明的特别示例通路配置仅是通过多室冷板30、32的通路流体的一个示例。
实际上,除了通过冷却剂室的流体流是并行的之外,图6示出的是与图5示出的系统相似的系统。两个冷却剂室均可以与冷却剂入口节气室200连通,其中冷却剂通过节气室200流入并行的各冷却剂室42、94。此外,两个冷却剂室均可以与冷却剂出口节气室202连通,其中冷却剂通过节气室202流出并行的各冷却剂室42、94返回压缩机。
现在可以理解的是,在血管内热交换模式中,来自导管12、流过布置在槽34中的盒50的工作流体通过各内壁84与冷却剂室42、94中的冷却剂交换热量。因为导管工作流体流过盒50,所以导管工作流体不与冷板热交换器的任何部分接触。以这种方式,导管工作流体维持其无菌性并且被包围在封闭的流体回路中以承受例如上至七十磅每平方英寸(70psi)的循环流体压力。
另一方面,因为垫片工作流体通过外部垫片与患者分隔,所以可以不要求垫片工作流体的无菌性,在这种情况下垫片工作流体可以直接在冷板30、32中接触分隔板82以与冷却剂室42、94中的冷却剂交换热量。
图7示出可选的冷板组件700,其具有盒槽34’和用于接收盒50的侧导轨的跨立槽34’的导轨收容部R1’和R2’,而收容部和槽与图2示出的对应部分在构造和功能上大致相同。然而,与图2不同,图7示出了在各收容部R1’、R2’的内侧,冷板组件700形成有可以大致延伸侧导轨收容部的整个长度(多或少几毫米)的各凸起或膨胀腔702、收容部或凹槽。在实施方式中,各凸起腔702可以是圆形或半圆形的(尽管可以使用其它形状)。凸起腔可以限定在冷板30’、32’之间。冷板30’和/或32’可以在其内壁形成腔或凹槽。腔或凹槽可以例如通过冷板的平台(landing)或其它段与侧导轨收容部分离或间隔开,使得凸起腔与侧导轨收容部分离或间隔开。这可以在膜充填工作流体时帮助最小化或防止膜组件膨胀进入侧导轨收容部。凸起腔在半圆的顶点处与槽34’接合或连接,例如半圆形凸起腔可以接合槽34’。如图7所示,各凸起腔702在其最宽点处可以具有的宽度W或直径(例如,圆或半圆的直径)小于导轨收容部的横向直径或宽度W2但大于槽34’的宽度W3。在其它实施方式中,凸起腔可以在导轨收容部的紧接内侧。
利用该结构,当盒50与冷板组件700接合而膜组件64布置在槽34’中并且盒的导轨布置在导轨收容部R1’、R2’中时,例如靠近膜组件64的边缘并在盒的侧导轨内侧的部分的膜组件的部分能够在膜组件64充填工作流体时扩展进入凸起腔702。这建立了沿着膜组件64的竖直侧边缘的扩大的流体供给和返回通道。以这种方式,沿着一条侧导轨进入盒50的顶部的工作流体主要顺着已经在凸起腔内扩展的膜组件的部分的流体供给通道向下流动。盒50上的流体供给管可以定位成使盒50上的流体供给管与凸起腔同心或成直线。随着流体从流体供给通道顺着供给通道向下流动,供给流体的部分逐渐出现,该部分遍及膜组件地流动到流体返回通道,其中流体返回通道由已经在紧邻盒50上的流体返回管的凸起腔702内扩展的膜组件的部分建立。
图8示出了除了以下例外,与图5和图6示出的冷板在构造和操作上大致相同的可选冷板800。分隔板802可以具有流路804、806(可以构造成与图3示出的蛇行流路42相同或构造成另一样式或形状,例如,具有一个或多个曲线、转弯和/或弯折),其中流路804、806形成于分隔板802的各侧表面。如同在本文中示出和讨论的另一冷板结构,分隔板802是高度导热的并且可以由金属、合适的热塑性塑料或其它传热材料制成。
左、右垫板808、810能够沿着分隔板的整个侧面抵接分隔板802的左右两侧,而仅流路804、806建立各流体可以流动通过的腔。(图9示出800的分解图)。因此,冷却剂可以流过分隔板802与左垫板808之间的左流路804,并且,例如来自患者热交换垫片或来自诸如可以用作储热单元的水储存部等的除了垫片之外的水源的来自图1的管路L3、L4的水可以通过右流路806在分隔板802与右垫板810之间流动。在该构造中,盒槽34’可以如所示出的位于左垫板808的与分隔板802相反的那侧。利用该结构,不仅冷却剂能够与盒中的无菌导管12的盐水或者来自垫片18的非无菌流体或可选地盒中的垫片流体交换热量,而且在冷却剂不可用或仅有电池电源可用的情况下(因此压缩机22实际上未联机),来自冷流体源28(图1示出)或水储存部(例如,水被压缩机先前冷却过的地方)的水可以被转入右流路806,以隔着分隔板802和左垫板808地提供与槽34’中的盒50的一些热交换。
该特定的实施方式,本文中说明的各种冷组件可以通过例如在炉中将板钎焊在一起和/或例如通过真空钎焊进行组装。板还可以或可选地通过机械紧固件连接以及利用O型环密封,和/或可以使用密封垫密封。
如果需要,当例如达到目标温度时,可以允许冷却剂变暖以加热本冷板,避免患者过冷和/或逆运行系统泵来缩短x型探针的均等间隔(equalizationstops)。另外,可以建立或调节冷却剂流以在冷却剂流过或横贯冷板的通道的整个时段内,大致为整个时段或部分时段内维持冷却剂的至少一些液相以促进热交换,其中冷却剂可以与来自血管内热交换导管和/或外部热交换垫片的工作流体交换热量。
如以上所讨论的,在内部冷却的过程中,使用图1的管道27可以使患者18通过来自压缩机22的排放热从外部温暖而获得舒适,或在冷却之后再温暖患者。在特定的实施方式中,通过系统10,例如通过压缩机或系统的任何其它部件产生的热量可以被传送或引导至患者的表面以在利用热交换导管或垫片冷却患者之前、之后或过程中温暖患者,以便例如防止或减少寒颤。在特定的变型中,可以经由加温器或医院中使用的其它热空气毯或帐篷将热量引导至患者以帮助保持患者的皮肤温暖。温暖患者的其它机制或方式包括但不限于:在垫片内放置或包括电加热元件;利用辐射加热灯温暖患者;将暖空气从控制台或系统上的将热量从压缩机移除的风扇引导至或朝向患者的表面;以及在系统中设置或包括容纳有温暖流体的第三流体回路。
尽管在本文中示出和详细说明了用于血管内温度管理导管和/或热交换垫片的热交换器中的冷板设计的各种实施方式,但本发明的范围不受除了所附权利要求之外的任何限制。包括在一个实施方式中的部件能够以任何适当的组合使用于其它实施方式中。例如,本文中说明和/或图中绘出的各种部件的任意部件可以被组合、互换或从其它实施方式中排除。
“具有A、B和C中的至少一者的系统”(同样地,“具有A、B或C中的至少一者的系统”和“具有A、B、C中的至少一者的系统”)包括具有单独的A、单独的B、单独的C、A和B一起、A和C一起、B和C一起和/或A、B和C一起等的系统。

Claims (25)

1.一种装置,其包括:
板组件,所述板组件具有被构造成接收盒的膜组件的盒槽,其中所述膜组件被构造成容纳来自血管内热交换导管或热交换垫片的工作流体,所述板组件还包括跨立所述槽的各侧并且被构造成接收所述盒的各侧导轨的导轨收容部,其中
至少第一腔在第一个所述导轨收容部的内侧形成,所述第一腔在其最宽点具有大于所述槽的宽度的宽度。
2.根据权利要求1所述的装置,其特征在于,所述装置包括在第二个所述导轨收容部的内侧形成的第二腔,所述第二腔在其最宽点具有大于所述槽的宽度的宽度。
3.根据权利要求1所述的装置,其特征在于,当通过使所述膜组件布置在所述槽中并且使所述盒的侧导轨布置在所述导轨收容部中而使所述盒与所述装置接合时,在所述盒的侧导轨的内侧的所述膜组件的第一部分能够在所述膜组件充填工作流体时扩展进入所述第一腔,从而沿着所述膜组件的竖直侧边缘建立放大的流体通道。
4.根据权利要求1所述的装置,其特征在于,所述第一腔大致延伸所述第一导轨收容部的整个长度。
5.根据权利要求1所述的装置,其特征在于,所述第一腔是圆形或半圆形的。
6.一种装置,其包括:
板组件,其包括:
分隔板,在所述分隔板的第一侧形成有第一流路,在所述分隔板的与所述第一侧相反的第二侧形成有第二流路;
所述第一流路被构造成接收来自压缩机的通过所述压缩机的冷却剂,所述第二流路被构造成接收来自患者热交换垫片或来自除所述垫片之外的流体源的流体;
第一垫板,其抵接所述分隔板的所述第一侧;
第二垫板,其抵接所述分隔板的所述第二侧;以及
腔,其与和所述分隔板相对的所述第一垫板接界并且被构造成接收盒,其中所述盒被构造成保持循环通过血管内热交换导管的工作流体。
7.根据权利要求6所述的装置,其特征在于,所述第一垫板沿着所述分隔板的整个所述第一侧抵接所述分隔板的所述第一侧,所述第二垫板沿着所述分隔板的整个所述第二侧抵接所述分隔板的所述第二侧,而所述分隔板的仅所述第一流路和所述第二流路建立了各流体能够流过的腔。
8.根据权利要求6所述的装置,其特征在于,至少所述第一流路是蛇行形状的。
9.根据权利要求6所述的装置,其特征在于,所述第一流路中的冷却剂能够与布置在所述腔中的盒内的流体交换热量。
10.根据权利要求6所述的装置,其特征在于,所述第一流路中的冷却剂能够隔着所述分隔板与所述第二流路中的流体交换热量。
11.根据权利要求6所述的装置,其特征在于,所述第二流路中的流体能够隔着所述分隔板和所述第一垫板与布置在所述腔中的盒内的流体交换热量。
12.根据权利要求6所述的装置,其特征在于,所述分隔板由金属制成。
13.根据权利要求6所述的装置,其特征在于,所述分隔板由热塑性塑料制成。
14.根据权利要求6所述的装置,其特征在于,建立通过所述第一流路的冷却剂流以遍及通过所述第一流路的冷却剂的横断面地维持一些液相。
15.一种热交换系统,其与来自血管内热交换导管或来自外部热交换垫片的工作流体交换热量,其包括:
至少一个压缩机,所述压缩机被构造成使冷却剂循环通过所述系统以与所述工作流体交换热量;以及
至少一个管道或管,所述管道或管被构造成接收来自所述压缩机的排放热并且将排放热引导至患者。
16.根据权利要求15所述的系统,其特征在于,所述系统将与来自血管内热交换导管的工作流体交换热量。
17.根据权利要求15所述的系统,其特征在于,所述系统将与来自外部热交换垫片的工作流体交换热量。
18.根据权利要求15所述的系统,其特征在于,所述管道与布置在患者周围的帐篷接合。
19.一种热交换系统,其与来自血管内热交换导管或来自外部热交换垫片的工作流体交换热量,其包括:
板组件,所述板组件具有被构造成接收通过流路的冷却剂的一个或多个流路,其中建立或调节通过流路的冷却剂流以遍及通过所述流路的冷却剂的横断面地维持至少一些液相,其中所述冷却剂与来自所述血管内热交换导管和/或所述外部热交换垫片的工作流体交换热量。
20.根据权利要求19所述的系统,其特征在于,建立或调节通过流路的冷却剂流以在所述冷却剂流过或横贯所述流路的整个时段内维持所述冷却剂的至少一些液相。
21.根据权利要求2所述的装置,其特征在于,所述第二腔在其最宽点具有小于所述第一导轨收容部或所述第二导轨收容部的宽度但大于所述槽的宽度的宽度。
22.根据权利要求1所述的装置,其特征在于,所述板组件的被构造成面对所接收的盒膜的表面涂布有非粘附或疏水的涂层以帮助在使用之后移除所述盒。
23.根据权利要求11所述的装置,其特征在于,所述流体是接收自水储存部或容器的水。
24.根据权利要求15所述的系统,其特征在于,所述板组件的被构造成面对所接收的盒膜的表面涂布有非粘附或疏水的涂层以帮助在使用之后移除所述盒。
25.根据权利要求1所述的装置,其特征在于,所述第一腔是凸起腔。
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US20200261263A1 (en) 2020-08-20
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